The oral TYK2 inhibitor demonstrates significant potential for treating active psoriatic arthritis in adults.
Bristol Myers Squibb (BMS) has announced positive top-line results from two Phase 3 trials of its oral TYK2 inhibitor, Sotyktu (deucravacitinib), for the treatment of active psoriatic arthritis (PsA). The data, drawn from the POETYK PsA-1 and POETYK PsA-2 trials, highlight Sotyktu’s potential as an effective treatment option for PsA, a debilitating condition that affects many individuals with psoriasis.
The POETYK PsA-1 trial assessed the drug in patients who had not previously received biologic disease-modifying antirheumatic drugs (bDMARD-naive), while the POETYK PsA-2 trial included both bDMARD-naive patients and those who had previously been treated with TNFα inhibitors. The results revealed that a significantly higher proportion of patients on Sotyktu achieved at least a 20% improvement in the signs and symptoms of PsA compared to those on a placebo after just 16 weeks of treatment.
Psoriatic arthritis, an immune-mediated disease affecting the joints, develops in approximately 30% of people living with psoriasis, a chronic skin condition that causes widespread inflammation. PsA is marked by joint pain, stiffness, and swelling, and can significantly impact a patient’s quality of life. Currently, more than eight million people in the United States are living with psoriasis, making the need for effective treatments for PsA even more urgent.
BMS confirmed that the trials met all primary and secondary endpoints, including improvements in PsA disease activity at the 16-week mark. The company also emphasized that Sotyktu’s safety profile was consistent with previous findings, which bodes well for its potential use in PsA treatment.
“We are excited by the positive data across both Phase 3 trials, which demonstrate the potential of oral Sotyktu as the first TYK2 inhibitor for people living with PsA,” said Roland Chen, Senior Vice President and Head of Immunology, Cardiovascular, and Neuroscience Development at BMS. “We look forward to discussing these results with health authorities as we work towards bringing this promising therapy to patients.”
Sotyktu is already approved in several major markets for the treatment of moderate-to-severe plaque psoriasis, where it has been shown to improve skin clearance, reduce symptom burden, and enhance patients’ quality of life. Additionally, BMS recently presented encouraging results from the Phase 3b/4 PSORIATYK SCALP study, which evaluated Sotyktu in patients with moderate-to-severe scalp psoriasis. Data shared at the 2024 European Academy of Dermatology and Venereology Congress showed that Sotyktu significantly outperformed placebo in improving scalp-specific physician’s global assessment scores and alleviating scalp-related itch.
With these promising results, Sotyktu is poised to become a leading treatment option for both plaque psoriasis and psoriatic arthritis, offering hope to millions of patients who are seeking better ways to manage these challenging conditions.
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